Trial Outcomes & Findings for Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device (NCT NCT04925271)

Results Overview

The time required to close the defect using the device

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

At time of endoscopy

Results posted on

2023-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	X-Tack The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. X-Tack: The mucosal or submucosal defect is closed with X-Tack.	Overstitch The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. Overstitch: The mucosal or submucosal defect is closed with Overstitch.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	X-Tack n=20 Participants The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. X-Tack: The mucosal or submucosal defect is closed with X-Tack.	Overstitch n=20 Participants The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. Overstitch: The mucosal or submucosal defect is closed with Overstitch.	Total n=40 Participants Total of all reporting groups
Age, Customized Age	61.8 years STANDARD_DEVIATION 13.5 • n=5 Participants	62.2 years STANDARD_DEVIATION 12.2 • n=7 Participants	62 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of endoscopy

The time required to close the defect using the device

Outcome measures

Outcome measures
Measure	X-Tack n=20 Participants The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. X-Tack: The mucosal or submucosal defect is closed with X-Tack.	Overstitch n=20 Participants The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. Overstitch: The mucosal or submucosal defect is closed with Overstitch.
Time to Closure	23.3 minutes Standard Deviation 13.9	18.4 minutes Standard Deviation 16.9

SECONDARY outcome

Timeframe: At time of endoscopy

Either crossover to the other study group per endoscopist's discretion, or the need for additional modalities to close the defect such as endoscopic clips

Outcome measures

Outcome measures
Measure	X-Tack n=20 Participants The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. X-Tack: The mucosal or submucosal defect is closed with X-Tack.	Overstitch n=20 Participants The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. Overstitch: The mucosal or submucosal defect is closed with Overstitch.
Incomplete Closure	2 Participants	3 Participants

Adverse Events

X-Tack

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Overstitch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	X-Tack n=20 participants at risk The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. X-Tack: The mucosal or submucosal defect is closed with X-Tack.	Overstitch n=20 participants at risk The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. Overstitch: The mucosal or submucosal defect is closed with Overstitch.
Gastrointestinal disorders Delayed bleeding	10.0% 2/20 • 2 weeks	0.00% 0/20 • 2 weeks

Other adverse events

Adverse event data not reported

Additional Information

Anand Kumar, Associate Professor of Medicine

Thomas Jefferson University

Phone: 215-955-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place